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Enrolling by invitationEarly Phase 1

Acute Effects of a Single Dose of Ayahuasca on Cerebral Metabolism in Healthy Volunteers: a PET Study

NCT07893912 · University of Sao Paulo

Closed to entry
Status
Not accepting participants
Early Phase 1
Phase
15
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

Open-label trial with healthy adults

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • regional cerebral glucose metabolic rate (CMRglu) with [18F]-FDG PET

    Measured over Baseline to 4 hours post-drug

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 60 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: * Healthy adults Exclusion Criteria: * Current or past history of cardiovascular disease, uncontrolled diabetes, liver disease, brain injury, head trauma with loss of consciousness, or other neurological and neurocognitive conditions; * any psychiatric diagnosis, assessed via the M.I.N.I. psychiatric interview (DSM-IV); * pregnant or breastfeeding women; prior experience (\>2 lifetime uses) with ayahuasca; * current use of psychoactive medications (antidepressants, mood stabilizers, anxiolytics, stimulants, and antipsychotics); * marijuana use (more than 20 times in a lifetime); use of other drugs (psychostimulants: maximum of 20 lifetime uses; hallucinogens: maximum of 5 lifetime uses); * known allergy to the radiopharmaceutical used; * exposure to ionizing radiation within the past year; claustrophobia; or any other reason preventing the performance of the PET/CT scan.

Where

1 study site

FacilityCityRegionCountry
Universidade de São PauloRibeirão Preto-Brazil

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record. The registry also holds the most current version of everything above.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07893912 on ClinicalTrials.gov →

Last updated in the registry 2026-10-26. Registry records change; this page reflects the data build of 2026-10-30.

Related

Where this trial sits